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    Clinical Trial Results:
    A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis

    Summary
    EudraCT number
    		 2019-003211-57
    Trial protocol
    		 SK   NO   GB   PT   DE   SE   DK   GR   LV   ES   HR   FR   IT   RO  
    Global end of trial date
    13 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2024
    First version publication date
    18 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457Q12301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04181762
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PACTR: PACTR202211748997845
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate that Secukinumab 300 mg was superior to placebo in Complete Renal Response (CRR) rate at Week 52 in active lupus nephritis (International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV, with or without co-existing Class V features) patients on a background of Standard of Care (SoC) therapy
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Brazil: 15
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Chile: 6
    Country: Number of subjects enrolled
    China: 40
    Country: Number of subjects enrolled
    Colombia: 19
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Guatemala: 10
    Country: Number of subjects enrolled
    India: 4
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Peru: 6
    Country: Number of subjects enrolled
    Philippines: 14
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    Thailand: 13
    Country: Number of subjects enrolled
    Türkiye: 5
    Country: Number of subjects enrolled
    United States: 14
    Country: Number of subjects enrolled
    Viet Nam: 28
    Worldwide total number of subjects
    275
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    273
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 106 centers in 34 countries worldwide.

    Pre-assignment
    Screening details
    		 At Baseline, all eligible subjects were randomized in a 1:1 ratio to secukinumab 300 mg s.c. or placebo via Interactive Response Technology (IRT).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 300 mg
    Arm description
    		 A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 786 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    AIN457
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.

    Arm title
    		 Placebo
    Arm description
    		 A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 794 days).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.

    Number of subjects in period 1
    		Secukinumab 300 mg Placebo
    Started
    137
    138
    Full Analysis Set 2
    91
    91
    Pharmacokinetic Set
    136
    0 [1]
    Completed
    23
    23
    Not completed
    114
    115
         Adverse event, serious fatal
    1
    1
         Physician decision
    1
    3
         Adverse event, non-fatal
    1
    3
         Subject decision
    11
    4
         Protocol deviation
    1
    -
         Pregnancy
    -
    1
         Study terminated by sponsor
    95
    97
         Lost to follow-up
    1
    1
         Withdrawal of informed consent
    1
    3
         Lack of efficacy
    2
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Pharmacokinetic Set = All subjects who had at least one PK/PD assessment and received at least one dose of study drug (Does not apply to Placebo arm

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 786 days).

    Reporting group title
    Placebo
    Reporting group description
    		 A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 794 days).

    Reporting group values
    		 Secukinumab 300 mg Placebo Total
    Number of subjects
    		 137 138 275
    Age Categorical
    Units: Participants
        < 30 years
    		 55 64 119
        >= 30 years
    		 82 74 156
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 34.1 ( 10.84 ) 33.2 ( 11.28 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 116 124 240
        Male
    		 21 14 35
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 21 21 42
        Asian
    		 67 56 123
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 6 9 15
        White
    		 42 52 94
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 786 days).

    Reporting group title
    Placebo
    Reporting group description
    		 A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter (maximum treatment exposure during the core study: 794 days).

    Primary: Percentage of participants achieving Complete Renal Response (CRR) at Week 52

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    End point title
    		 Percentage of participants achieving Complete Renal Response (CRR) at Week 52
    End point description
    Complete Renal Response (CRR) is a composite endpoint defined as: ● Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73 m^2 or no less than 85% of core Baseline values and ● 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =< 0.5mg/mg ● No treatment discontinuation before Week 52 ● The subject did not receive more than 10 mg/day prednisone or equivalent for >= 3 consecutive days or for >= 7 days in total during Week 44 through Week 52. Non-responder imputation (NRI) was used for participants who did not have the required data to compute responses at Week 52 or who had discontinued study treatment before Week 52. A logistic regression model was used for the analysis of this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    91
    91
    Units: Percentage of participants
        number (confidence interval 95%)
    25.9 (16.8 to 34.9)
    38.6 (28.5 to 48.7)
    Statistical analysis title
    		 Complete Renal Response (CRR) at Week 52
    Comparison groups
    Secukinumab 300 mg v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0662
    Method
    		 Regression, Logistic
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.3
         upper limit
    		 0.9

    Secondary: Change from Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)

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    End point title
    		 Change from Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR)
    End point description
    Urine Protein-to-Creatinine Ratio (UPCR) was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected (24-hour urine collection sample).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    67
    63
    Units: mg/mg
        arithmetic mean (standard deviation)
    -2.204 ( 3.5162 )
    -2.741 ( 5.9448 )
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving Partial Renal Response (PRR) at Week 52

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    End point title
    		 Percentage of participants achieving Partial Renal Response (PRR) at Week 52
    End point description
    Partial Renal Response (PRR) is a composite endpoint defined as: ● >= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=< 3 mg/mg) and ● Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73 m^2 or no less than 85% of Baseline
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    73
    72
    Units: Percentage of participants
        number (confidence interval 95%)
    56.2 (44.1 to 67.8)
    63.9 (51.7 to 74.9)
    Statistical analysis title
    		 Partial Renal Response (PRR) at Week 52
    Comparison groups
    Secukinumab 300 mg v Placebo
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.7
         upper limit
    		 8.4

    Secondary: Incidence rate of participants achieving Complete Renal Response (CRR) up to Week 52

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    End point title
    		 Incidence rate of participants achieving Complete Renal Response (CRR) up to Week 52
    End point description
    Time to achieve Complete Renal Response (CRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve CRR were censored at the date of their last non-missing CRR result (including participants who completed week 52 without achieving CRR). * Subjects at risk = Subjects who did not achieve CRR and were not censored before or at the start of the specified interval. Participants had an event when achieving CRR. * Incidence rate (%) = (number of subjects with event/number of subjects at risk) x 100.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    131
    132
    Units: Percentage of participants
    number (not applicable)
        1 to 28 days
    0.0
    0.8
        29 to 56 days
    0.0
    0.0
        57 to 84 days
    3.1
    5.4
        85 to 112 days
    11.7
    16.8
        113 to 140 days
    0.0
    2.2
        141 to 168 days
    0.0
    3.4
        169 to 196 days
    20.4
    20.0
        197 to 224 days
    1.4
    0.0
        225 to 252 days
    0.0
    0.0
        253 to 280 days
    14.8
    3.6
        281 to 308 days
    0.0
    2.1
        309 to 336 days
    0.0
    0.0
        337 to 364 days
    2.3
    7.3
    No statistical analyses for this end point

    Secondary: Average daily dose of oral corticosteroids

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    End point title
    		 Average daily dose of oral corticosteroids
    End point description
    Average daily dose of oral corticosteroids doses was used to assess efficacy of secukinumab compared to placebo in the averaged daily dose of oral corticosteroids administered between Week 16 and Week 52.
    End point type
    Secondary
    End point timeframe
    Week 16 to Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    137
    138
    Units: mg/day
        arithmetic mean (standard deviation)
    8.1243 ( 6.38329 )
    7.4791 ( 5.61958 )
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving Partial Renal Response (PRR) at Week 24

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    End point title
    		 Percentage of participants achieving Partial Renal Response (PRR) at Week 24
    End point description
    Partial Renal Response (PRR) is a composite endpoint defined as: ● >= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=< 3 mg/mg) and ● Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73 m^2 or no less than 85% of Baseline
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    108
    110
    Units: Percentage of participants
        number (confidence interval 95%)
    52.8 (42.9 to 62.5)
    43.6 (34.2 to 53.4)
    No statistical analyses for this end point

    Secondary: Incidence rate of participants achieving Partial Renal Response (PRR) up to Week 52

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    End point title
    		 Incidence rate of participants achieving Partial Renal Response (PRR) up to Week 52
    End point description
    Time to achieve Partial Renal Response (PRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve PRR were censored at the date of their last non-missing PRR result (including participants who completed week 52 without achieving PRR). Participants had event when achieving PRR. * Subjects at risk = Subjects who did not achieve PRR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    131
    132
    Units: Percentage of participants
    number (not applicable)
        1 to 28 days
    0.0
    0.8
        29 to 56 days
    0.0
    0.0
        57 to 84 days
    7.0
    5.4
        85 to 112 days
    27.8
    30.5
        113 to 140 days
    1.3
    2.6
        141 to 168 days
    0.0
    4.1
        169 to 196 days
    32.4
    14.9
        197 to 224 days
    2.4
    0.0
        225 to 252 days
    2.6
    0.0
        253 to 280 days
    11.8
    16.3
        281 to 308 days
    4.0
    2.9
        309 to 336 days
    0.0
    0.0
        337 to 364 days
    0.0
    6.5
    No statistical analyses for this end point

    Secondary: Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to week 52

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    End point title
    		 Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to week 52
    End point description
    Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve UCPR were censored at the date of their last non-missing UCPR result (including participants who completed week 52 without achieving UCPR). Participants had event when achieving UCPR. * Subjects at risk = Subjects who did not achieve UCPR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    135
    136
    Units: Percentage of participants
    number (not applicable)
        1 to 28 days
    19.3
    21.3
        29 to 56 days
    2.8
    5.6
        57 to 84 days
    8.7
    7.0
        85 to 112 days
    11.8
    9.7
        113 to 140 days
    7.6
    7.4
        141 to 168 days
    9.9
    6.9
        169 to 196 days
    9.7
    3.2
        197 to 224 days
    7.5
    11.9
        225 to 252 days
    4.2
    6.0
        253 to 280 days
    4.4
    0.0
        281 to 308 days
    12.2
    4.5
        309 to 336 days
    0.0
    5.1
        337 to 364 days
    3.1
    2.9
    No statistical analyses for this end point

    Secondary: Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) mean change from Baseline up to Week 52

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    End point title
    		 Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) mean change from Baseline up to Week 52
    End point description
    The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past week. The purpose of the FACIT-Fatigue in this study was to assess the impact of fatigue on subjects with lupus nephritis (LN). The level of fatigue was measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT-Fatigue scale score range from 0 to 52, where higher scores represent less fatigue.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24, Week 36, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12
    -2.8 ( 8.47 )
    -1.9 ( 8.46 )
        Week 24
    -1.4 ( 9.66 )
    -2.0 ( 8.93 )
        Week 36
    -2.6 ( 9.21 )
    -2.1 ( 9.67 )
        Week 52
    -2.0 ( 10.18 )
    -2.0 ( 9.51 )
    No statistical analyses for this end point

    Secondary: Short Form Health Survey (SF-36) Version 2 (Acute Form) mean change from Baseline in Physical Component Score (PCS) up to Week 52

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    End point title
    		 Short Form Health Survey (SF-36) Version 2 (Acute Form) mean change from Baseline in Physical Component Score (PCS) up to Week 52
    End point description
    The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). In this trial, SF-36-PCS responder (improvement of >= 2.5 points) were evaluated. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS scores range 0 to 100).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24, Week 36, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12
    2.306 ( 6.4306 )
    2.210 ( 6.8760 )
        Week 24
    2.873 ( 6.4502 )
    1.687 ( 6.5346 )
        Week 36
    2.910 ( 6.8234 )
    3.152 ( 7.0623 )
        Week 52
    3.410 ( 7.7123 )
    2.707 ( 6.8887 )
    No statistical analyses for this end point

    Secondary: Lupus Quality of Life (LupusQoL) physical health score mean change from Baseline up to Week 52

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    End point title
    		 Lupus Quality of Life (LupusQoL) physical health score mean change from Baseline up to Week 52
    End point description
    The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of subjects with SLE within 8 domains (i.e., physical health (8 items), emotional health (6 items), body image (5 items), pain (3 items), planning (3 items), fatigue (4 items), intimate relationships (2 items), and burden to others (3 items)). Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). Each domain of the LupusQoL was scored separately. Transformed scores range from 0 (worst HRQoL) to 100 (best HRQoL).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 24, Week 36, Week 52
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    131
    131
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 12
    5.32 ( 16.031 )
    6.18 ( 19.248 )
        Week 24
    4.84 ( 18.184 )
    5.55 ( 20.485 )
        Week 36
    5.59 ( 20.684 )
    7.89 ( 23.112 )
        Week 52
    7.62 ( 23.275 )
    8.55 ( 20.589 )
    No statistical analyses for this end point

    Secondary: Incidence of adverse events (AEs), serious adverse events (SAEs)

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    End point title
    		 Incidence of adverse events (AEs), serious adverse events (SAEs)
    End point description
    The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment up to approximately 2 years
    End point values
    		 Secukinumab 300 mg Placebo
    Number of subjects analysed
    137
    138
    Units: Participants
        Deaths
    1
    1
        Serious Adverse Event (TESAEs)
    30
    39
        Treatment Emergent Adverse Event (TEAEs)
    120
    123
        TESAEs leading to study medication discontinuation
    8
    10
    No statistical analyses for this end point

    Secondary: Percentage of participants with improved or maintained response (PRR or CRR) at Week 104 in those who had achieved at least PRR at Week 52 in the secukinumab group

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    End point title
    		 Percentage of participants with improved or maintained response (PRR or CRR) at Week 104 in those who had achieved at least PRR at Week 52 in the secukinumab group [1]
    End point description
    The percentage of participants with improved or maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated
    End point type
    Secondary
    End point timeframe
    Week 52 to Week 104
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics performed
    End point values
    		 Secukinumab 300 mg
    Number of subjects analysed
    12
    Units: Participants
        Achieve PRR or CRR
    11
        Not achieve PRR or CRR
    1
    No statistical analyses for this end point

    Secondary: Percentage of participants with Complete Renal Response (CRR) at Week 104 within those who had achieved CRR at Week 52 in the secukinumab group

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    End point title
    		 Percentage of participants with Complete Renal Response (CRR) at Week 104 within those who had achieved CRR at Week 52 in the secukinumab group [2]
    End point description
    The percentage of participants with maintained renal response (CRR) at Week 104 in the secukinumab group was evaluated
    End point type
    Secondary
    End point timeframe
    Week 52 to Week 104
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics performed
    End point values
    		 Secukinumab 300 mg
    Number of subjects analysed
    6
    Units: Participants
        Achieve CRR
    5
        Not Achieve CRR
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment adverse events and deaths were reported from first dose of study treatment to 84 days after last dose of study medication, assessed up to approximately 2 years.
    Adverse event reporting additional description
    Any sign or symptom that occurred during the treatment and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg

    Serious adverse events
    		 Placebo AIN457 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 138 (28.26%)
    30 / 137 (21.90%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital tract inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incoherent
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    5 / 138 (3.62%)
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    4 / 138 (2.90%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 138 (2.90%)
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematological infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital herpes
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 137 (3.65%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo AIN457 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 138 (84.06%)
    111 / 137 (81.02%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 138 (5.80%)
    8 / 137 (5.84%)
         occurrences all number
    11
    11
    Hypotension
         subjects affected / exposed
    4 / 138 (2.90%)
    5 / 137 (3.65%)
         occurrences all number
    5
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 137 (2.92%)
         occurrences all number
    3
    4
    Chest discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 137 (2.19%)
         occurrences all number
    0
    5
    Oedema
         subjects affected / exposed
    4 / 138 (2.90%)
    2 / 137 (1.46%)
         occurrences all number
    4
    3
    Peripheral swelling
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 137 (2.92%)
         occurrences all number
    2
    4
    Pyrexia
         subjects affected / exposed
    3 / 138 (2.17%)
    8 / 137 (5.84%)
         occurrences all number
    6
    12
    Oedema peripheral
         subjects affected / exposed
    8 / 138 (5.80%)
    3 / 137 (2.19%)
         occurrences all number
    11
    4
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Menstruation irregular
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 137 (2.92%)
         occurrences all number
    1
    4
    Menstrual disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 137 (4.38%)
         occurrences all number
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    4 / 138 (2.90%)
    1 / 137 (0.73%)
         occurrences all number
    4
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 137 (2.19%)
         occurrences all number
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    4 / 138 (2.90%)
    4 / 137 (2.92%)
         occurrences all number
    5
    5
    Cough
         subjects affected / exposed
    14 / 138 (10.14%)
    8 / 137 (5.84%)
         occurrences all number
    20
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 138 (4.35%)
    8 / 137 (5.84%)
         occurrences all number
    7
    8
    Depression
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 137 (2.19%)
         occurrences all number
    2
    3
    Anxiety
         subjects affected / exposed
    4 / 138 (2.90%)
    3 / 137 (2.19%)
         occurrences all number
    4
    3
    Investigations
    Weight increased
         subjects affected / exposed
    3 / 138 (2.17%)
    4 / 137 (2.92%)
         occurrences all number
    3
    5
    White blood cell count decreased
         subjects affected / exposed
    3 / 138 (2.17%)
    2 / 137 (1.46%)
         occurrences all number
    3
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 138 (2.90%)
    2 / 137 (1.46%)
         occurrences all number
    4
    2
    Nervous system disorders
    Tremor
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 137 (2.19%)
         occurrences all number
    3
    3
    Headache
         subjects affected / exposed
    14 / 138 (10.14%)
    21 / 137 (15.33%)
         occurrences all number
    26
    34
    Dizziness
         subjects affected / exposed
    3 / 138 (2.17%)
    6 / 137 (4.38%)
         occurrences all number
    3
    7
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    10 / 138 (7.25%)
    6 / 137 (4.38%)
         occurrences all number
    12
    9
    Lymphopenia
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 137 (2.19%)
         occurrences all number
    1
    3
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 138 (2.90%)
    3 / 137 (2.19%)
         occurrences all number
    5
    3
    Anaemia
         subjects affected / exposed
    13 / 138 (9.42%)
    12 / 137 (8.76%)
         occurrences all number
    13
    12
    Neutropenia
         subjects affected / exposed
    3 / 138 (2.17%)
    3 / 137 (2.19%)
         occurrences all number
    5
    5
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 137 (2.19%)
         occurrences all number
    2
    4
    Vision blurred
         subjects affected / exposed
    6 / 138 (4.35%)
    3 / 137 (2.19%)
         occurrences all number
    6
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 138 (4.35%)
    3 / 137 (2.19%)
         occurrences all number
    8
    3
    Abdominal pain upper
         subjects affected / exposed
    4 / 138 (2.90%)
    2 / 137 (1.46%)
         occurrences all number
    4
    2
    Aphthous ulcer
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 137 (2.19%)
         occurrences all number
    2
    4
    Constipation
         subjects affected / exposed
    6 / 138 (4.35%)
    1 / 137 (0.73%)
         occurrences all number
    7
    1
    Diarrhoea
         subjects affected / exposed
    21 / 138 (15.22%)
    23 / 137 (16.79%)
         occurrences all number
    30
    25
    Dyspepsia
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 137 (3.65%)
         occurrences all number
    2
    7
    Gastritis
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 137 (2.92%)
         occurrences all number
    2
    4
    Nausea
         subjects affected / exposed
    5 / 138 (3.62%)
    11 / 137 (8.03%)
         occurrences all number
    11
    17
    Mouth ulceration
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 137 (3.65%)
         occurrences all number
    5
    8
    Haemorrhoids
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 137 (2.19%)
         occurrences all number
    1
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 138 (3.62%)
    2 / 137 (1.46%)
         occurrences all number
    5
    2
    Toothache
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 137 (2.19%)
         occurrences all number
    2
    8
    Vomiting
         subjects affected / exposed
    4 / 138 (2.90%)
    7 / 137 (5.11%)
         occurrences all number
    5
    9
    Skin and subcutaneous tissue disorders
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 137 (3.65%)
         occurrences all number
    1
    5
    Rash erythematous
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 137 (0.00%)
         occurrences all number
    3
    0
    Rash
         subjects affected / exposed
    5 / 138 (3.62%)
    1 / 137 (0.73%)
         occurrences all number
    6
    2
    Pruritus
         subjects affected / exposed
    3 / 138 (2.17%)
    4 / 137 (2.92%)
         occurrences all number
    3
    8
    Erythema
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Dry skin
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 137 (2.19%)
         occurrences all number
    0
    3
    Dermatitis allergic
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 137 (0.00%)
         occurrences all number
    3
    0
    Alopecia
         subjects affected / exposed
    11 / 138 (7.97%)
    6 / 137 (4.38%)
         occurrences all number
    15
    6
    Acne
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    3 / 138 (2.17%)
    2 / 137 (1.46%)
         occurrences all number
    4
    2
    Acute kidney injury
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 137 (4.38%)
         occurrences all number
    3
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 138 (13.77%)
    13 / 137 (9.49%)
         occurrences all number
    36
    19
    Back pain
         subjects affected / exposed
    4 / 138 (2.90%)
    5 / 137 (3.65%)
         occurrences all number
    6
    5
    Systemic lupus erythematosus
         subjects affected / exposed
    4 / 138 (2.90%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Pain in extremity
         subjects affected / exposed
    4 / 138 (2.90%)
    0 / 137 (0.00%)
         occurrences all number
    5
    0
    Muscle spasms
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 137 (4.38%)
         occurrences all number
    5
    9
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 137 (4.38%)
         occurrences all number
    0
    6
    Bronchitis
         subjects affected / exposed
    3 / 138 (2.17%)
    3 / 137 (2.19%)
         occurrences all number
    4
    3
    COVID-19
         subjects affected / exposed
    22 / 138 (15.94%)
    25 / 137 (18.25%)
         occurrences all number
    23
    26
    Conjunctivitis
         subjects affected / exposed
    4 / 138 (2.90%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Gastroenteritis
         subjects affected / exposed
    7 / 138 (5.07%)
    6 / 137 (4.38%)
         occurrences all number
    7
    6
    Herpes zoster
         subjects affected / exposed
    7 / 138 (5.07%)
    10 / 137 (7.30%)
         occurrences all number
    7
    10
    Influenza
         subjects affected / exposed
    3 / 138 (2.17%)
    3 / 137 (2.19%)
         occurrences all number
    6
    4
    Nasopharyngitis
         subjects affected / exposed
    11 / 138 (7.97%)
    11 / 137 (8.03%)
         occurrences all number
    21
    14
    Pharyngitis
         subjects affected / exposed
    11 / 138 (7.97%)
    4 / 137 (2.92%)
         occurrences all number
    12
    4
    Oral herpes
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 137 (3.65%)
         occurrences all number
    3
    6
    Oral candidiasis
         subjects affected / exposed
    3 / 138 (2.17%)
    8 / 137 (5.84%)
         occurrences all number
    4
    12
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 138 (18.84%)
    19 / 137 (13.87%)
         occurrences all number
    30
    26
    Urinary tract infection
         subjects affected / exposed
    30 / 138 (21.74%)
    19 / 137 (13.87%)
         occurrences all number
    41
    28
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    5 / 138 (3.62%)
    7 / 137 (5.11%)
         occurrences all number
    5
    7
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 137 (2.19%)
         occurrences all number
    1
    3
    Hyperlipidaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 137 (2.92%)
         occurrences all number
    1
    4
    Hyperuricaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 137 (5.11%)
         occurrences all number
    1
    7
    Hypocalcaemia
         subjects affected / exposed
    3 / 138 (2.17%)
    2 / 137 (1.46%)
         occurrences all number
    4
    2
    Hypokalaemia
         subjects affected / exposed
    11 / 138 (7.97%)
    9 / 137 (6.57%)
         occurrences all number
    14
    10
    Iron deficiency
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    3
    1
    Vitamin D deficiency
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 137 (0.73%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2023
    Amendment 1: The purpose of this amendment was to decrease the overall study sample size from 460 to 400 subjects based on literature reporting results of Phase 3 studies in adult lupus nephritis populations

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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